Kornimate/medical-research-clean huggingface dataset:
effects of recruitment maneuver on functional residual capacity

Conditions: Anesthesia; Surgery; Atelectasis

Summary: recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (frc) negatively. recently, frc can be measured at bedside in intensive care units. the lack of studies evaluating frc measurements peroperatively and how recruitment maneuvers affect it, attract attention.

an icu-ventilator capable to measure the frc will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with tiva. frc will be measured in different steps of the operation. in the study group, a recruitment manover will be applied to evaluate its effects on frc.

Eligibility criteria:
inclusion criteria: 1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery exclusion criteria: 1. \<18 years old 2. \>65 years old 3. denial of patient 4. patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
evaluation of deep transcranial magnetic stimulation (tms) h-coil in the treatment of major depression

Conditions: Major Depression

Summary: this study is evaluating the safety and feasibility of the novel deep tms h-coil designs in the treatment of resistant major depression in an open study using two different h-coil designs.


Eligibility criteria:
inclusion criteria: * patients diagnosed as suffering from treatment resistant major depression exclusion criteria: * other axis i diagnosis * risk factors for convulsions * electroconvulsive therapy (ect) in the last 9 months * history of drug abuse in the past year

Keywords: major depression tms
safety study to assess opiate withdrawal signs and symptoms in opioid dependent patients

Conditions: Chronic Pain

Summary: this study will evaluate whether crushed embeda capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on embeda.

the decision to terminate the trial was due to a lack of study drug supply. decision was not based on any safety concerns. the date of the notification of termination letter was march 11, 2011.

Eligibility criteria:
inclusion criteria: * chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment). * receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily. * patient displays signs and symptoms of withdrawal (i.e., cows score ≥5) following naloxone administration during the naloxone challenge. if female and able to become pregnant, must use an approved method of birth control. * excluding the chronic moderate to severe non-cancer pain, the patient is judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ecg). exclusion criteria: * female who is pregnant or breastfeeding. * patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds. * patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin). * history of, or ongoing, alcohol or drug abuse. * patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.

Keywords: opioid morphine naltrexone withdrawal signs withdrawal symptoms
extracorporeal specific ige removal from the plasma of allergic asthma patients (espira-study)

Conditions: Allergic Asthma

Summary: in this study patients suffering from immunoglobulin e (ige) mediated asthma are treated with a method, called immune apheresis, that removes ige from blood. in order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. the plasma passes the new ige adsorber where the ige is specifically bound. the "cleaned" plasma re-joined with the blood cells is given back to the patient. in total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. study hypothesis is that the new ige adsorber is capable of reducing ige in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. the new adsorber can be safely used in patients. a group of patients with conventional drug treatment and no apheresis treatment serves as control.


Eligibility criteria:
inclusion criteria: * signed informed consent * clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, ige serology * allergic asthma (diagnosed by lung specialist) * ige concentration in blood at least 300 kilo units (ku)/l exclusion criteria: * participation in another trial within 30 days prior to enrolment * gravidity (pregnancy test prior to each treatment cycle) * intake of omalizumab * hepatitis or hiv or malignant disease * specific immunotherapy in the last 6 months * non-allergic asthma * auto-immune diseases * hypocalcaemia * intake of ace-inhibitors (discontinuation according to half-time before treatment possible) * uncontrolled bleeding and coagulation disorders * severe cardiovascular disease * severe cardiac arrhythmias * severe systemic infection * unability to tolerate therapeutic apheresis procedures (hypersensitivity associated with previous apheresis sessions) * inadequate peripheral venous access * condition in which acute fluid shifts may cause congestive heart failure * established or suspected intra-cranial disease where fluid imbalance or pressure changes could exacerbate the disease * impaired renal function * clinically significant hypotension or borderline hypotension where a further drop in blood pressure could be harmful

Keywords: asthma, bronchial immunoadsorbents apheresis immunoglobulin e
meta-analysis accidental hypothermia in trauma

Conditions: Hypothermia; Trauma; Brain Injuries, Traumatic; Morality

Summary: this is a systematic literature review and meta-analysis investigating the effect of accidental hypothermia on mortality in trauma patients overall and patients with tbi specifically. literature search will be performed using the ovid medline/pubmed database. studies comparing the effect of hypothermia vs. normothermia at hospital admission on in-hospital mortality will be included in meta-analysis.

accidental hypothermia is a known predictor for worse outcomes in trauma patients, but has not been comprehensively assessed in meta-analysis so far. the aim of this systematic review and meta-analysis is to investigate the impact of accidental hypothermia on mortality in trauma patients overall and patients with traumatic brain injury (tbi) specifically. literature search will be conducted using the ovid medline/pubmed database. the search strategy will be based on the picos strategy. scientific articles reporting (1) accidental hypothermia in trauma patients overall or patients with tbi specifically, (2) body temperature and time of measurement, and (3) the impact of accidental hypothermia on outcomes will be included in the qualitative review. two meta-analyses will be performed including (1) trauma patients overall and (2) patients with tbi specifically. studies reporting in-hospital mortality of hypothermic and normothermic trauma patients overall or patients with tbi specifically, based on the temperature measured at emergency department admission, will be included in meta-analysis. meta-analysis will be performed using a mantel-haenszel random-effects model. the estimated effect size for mortality will be reported as odds ratio (or) and 95% confidence interval (ci) for each study as well as for the overall cohort.

Eligibility criteria:
inclusion criteria: * original scientific articles * english language * study in trauma patients * reported body temperature and time of temperature measurement * reported impact of accidental hypothermia on outcomes exclusion criteria: * case reports * systematic reviews * articles on therapeutic hypothermia
eoipb in laparoscopic cholecystectomy: impact on opioid consumption guided by ani and analgesia quality

Conditions: Pain Management; Laparoscopic Cholecystectomy Surgery

Summary: the aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.

routine anesthesia and analgesia protocol will be applied to all participants. the study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, analgesia nociception index, bispectral index). remifentanil level will be adjusted according to the ani value. the target is to keep the ani between 50-70.

Eligibility criteria:
inclusion criteria: * participants who will undergo elective laparoscopic cholecystectomy surgery, * age 18-70, * asa i-ii physical status, * body mass index (bmi) \< 35 kg/m², * participants who have written consent to participate in the study exclusion criteria: * participants with routine analgesic consumption, * those with coagulopathy, * those with a history of local anesthetic allergy, * those with cardiac arrhythmia and pacemaker, * asa iii and above, those with dementia

Keywords: external oblique intercostal plane block
assessing the efficacy of image-guided laser-assisted enstilar® delivery for treatment of psoriatic nails

Conditions: Nail Psoriasis

Summary: the trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (afl). it is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of enstilar® in treating nail psoriasis.


Eligibility criteria:
inclusion criteria 1. informed consent obtained before any trial-related activities. 2. at least 18 years of age (inclusive) 3. confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits 4. minimum nail involvement as assessed by treating physician (n-nail score of ≥ 2 for at least two individual nails) exclusion criteria 1. insufficient knowledge of written and spoken danish. 2. pregnant and lactating women and women who intend to become pregnant during the trial 3. pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers 4. presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment 5. any non-psoriatic disease activity within test areas 6. significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of enstilar is contraindicated. 7. known predisposition for hypertrophic scar formation. 8. known allergy to any of the components of enstilar®. 9. current treatment with systemically or locally acting medications which might counter or influence the trial aim 10. received any drug as part of a research trial within 30 days prior to initial trial dosing. 11. artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels. 12. ongoing fungal infections of psoriatic nails 13. close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor 14. in the opinion of the investigator, the participant is unlikely to comply with the clinical trial protocol (e.g. alcoholism, drug dependency or psychotic state).

Keywords: nail disease psoriasis laser-assisted drug delivery enstilar
pharmacokinetics of somatropin in patients with end stage renal disease receiving chronic haemodialysis

Conditions: Chronic Kidney Disease; End-Stage Renal Disease; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to to compare steady-state total growth hormone (gh) exposure in haemodialysis (hd) patients with that of matched healthy subjects.


Eligibility criteria:
inclusion criteria: * patients: * male or female, age equal to or above 18 years undergoing chronic haemodialysis * stable and adequate haemodialysis treatment three months prior to enrolment * healthy subjects: * matching an individual of the patient group by: gender and age (± 5 years) * matching an individual of the patient group by weight (after dialysis, ±10%) * creatinine clearance above 80 ml/min * subjects must be in good health in accordance with their age as determined by a medical * history, physical examination, vital signs, ecg (electrocardiogram), routine haematology and clinical chemistry exclusion criteria: * use of cuprophane membranes * active malignant disease * diabetes * critical illness as defined by the need of respiratory or circulatory support * known or suspected allergy to the trial product * pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be * using inadequate contraceptive measures * blood pressure (pre-dialysis) above 180/110 * chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent) * treated with immunosuppressive agents
safety and efficacy of lenvatinib in subjects with hcc progression after first line treatment with checkpoint inhibitors

Conditions: Hepatocellular Carcinoma

Summary: the objective of this study is to evaluate the efficacy of lenvatinib in hcc subjects who have progressive disease after first line treatment with checkpoint inhibitors. approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib. ct/mri assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. disease status will be determined at the site (ie. investigator and/or radiologist) using recist version 1.1. the primary efficacy endpoint is response rate (rr) defined as proportion of subjects with sd/pr/cr per recist 1.1.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old on the day of consent 2. capable of understanding and complying with the protocol requirements and signed informed consent 3. documented histological or cytological diagnosis of hcc 4. hcc progression after first line treatment with checkpoint inhibitors per recist 1.1 exclusion criteria: 1. fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma 2. prior tki treatment
effect of tdcs on chronic abdominal visceral pain in hcc patients

Conditions: Abdominal Pain

Summary: to evaluate the effect of transcranial direct current stimulation (tdcs) applied to the motor cortex to reduce chronic abdominal visceral pain in a group of participants with hepatocellular carcinoma

this study will be carried out in assiut university hospital pain clinic and in participation of department of neuropsychiatry in assiut university hospital. after obtaining approval of hospital ethical committee, informed written consent will be taken from all patients with malignant visceral pain to be involved in this study. in these study investigators test the hypothesis that does transcranial direct current stimulation induce analgesia in chronic abdominal visceral pain due to liver cancer ? preparation: the patient will seat in a comfortable chair and will be asked to relax as much as possible. tdcs was delivered using a battery driven dc stimulator (neuroconn gmbh,98693 llmenau, germany). current was delivered by electrodes encased in sponge pads soaked with 1% saline solution. the machine was kept behind the participant and out of their view at all times. for both the active and sham conditions, the anode was placed over the motor cortex of the patient and the cathode was placed over the contralateral supraorbital region. electrodes were secured using soft elastic straps. in the active stimulation condition a constant current of 2ma intensity was applied for 30 minutes with a 5-second ramp phase at the beginning. in the sham stimulation condition the machine was activated for 30 seconds using identical parameters but was then switched off without the patient's knowledge. this sham control is commonly employed because over the initial 30 seconds of stimulation, an initial sensation of tingling under the electrode fades away. patients are less likely to distinguish active from sham conditions if the initial period of tingling is present in both. patients were evaluated by verbal descriptor scale (vds), visual analog scale (vas), and hamilton rating scale for depression (ham-d) at the baseline, after 1st, 5th, 10th session, and 1 month after end of sessions.

Eligibility criteria:
inclusion criteria: * all patients of above 18 years old, with malignant visceral pain due to primary liver cancer or on top of cirrhosis, resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication will be involved in this study exclusion criteria: * investigators will exclude patients with intracranial metallic devices or with pacemakers or any other device. investigators also exclude those with extensive myocardial ischemia and those known to have epilepsy.

Keywords: tdcs cancer liver chronic abdominal pain vas vds ham-d bpi analgesia
abdominal transcutaneous electrical acupoint stimulation on children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism in Children

Summary: the goal of this clinical trial is to learn if abdominal transcutaneous electrical acupoint stimulation (abdominal teas) works to treat autism spectrum disorder (asd) in children. it will also learn about the safety of abdominal teas. the main questions it aims to answer are: does abdominal teas a safe and effective treatment for children with autism spectrum disorder and gastrointestinal symptoms? researchers will compare abdominal teas to a placebo (a sham abdominal teas without stimulation) to see if abdominal teas works to treat asd. participants will: take abdominal teas or sham abdominal teas 5 days a week for 8 weeks. visit the clinic once every 4 weeks for checkups and tests keep a diary of their symptoms.

following randomization, participants had an appointment with the teas operator. the teas operators had a minimum of 2 years of experience in acupuncture treatment and held a membership with a national professional association in china. the zhongwan (rn 12), bilateral tianshu (st 25), qihai (rn 6) and guanyuan (rn 4) acupuncture points were selected according to the concept of traditional chinese medicine that specialized in treating gastrointestinal diseases, improving intestinal function, and eliminating various symptoms caused by intestinal dysfunction.

Eligibility criteria:
inclusion criteria: * being diagnosed as autism based on the dsm-v and autism diagnostic observation schedule, second edition (ados-2) * aged 3 to 6 years exclusion criteria: * diagnosed with other organic diseases (such as severe hearing and visual impairment, brain trauma) and neurological disease (e.g., epilepsy, rett syndrome), or psychiatric disorder (schizophrenia, bipolar affective disorder, etc) * oral or injected antibiotics within 30 days before screening * history of acupuncture, electroacupuncture, teas treatment before screening * taking antipsychotic drugs and psychobiotic supplements within 30 days before screening

Keywords: transcutaneous electrical acupoint stimulation gastrointestinal symptoms children autism spectrum disorder
sphingolipidomic profile in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: : the objective of this research project will be to determine the sphingolipidomic profile in a group of women (\> 18 years) affected by anorexia nervosa (an), phenotypically characterized (restricting \[an-r\] vs binge-eating purging \[an-bp\]). specific questionnaires will be administered for the definition of the severity of the eating disorder and depressive state (suicidality), to which will be added the evaluation of gonadal function (i.e., plasma levels of estradiol/progesterone and use of oral contraceptives). based on the specific lipidomic profile, which the present research project hopes to characterize, it will be possible to appropriately modify the diet of rehabilitation programs and, in the future, improve the effectiveness of the treatment itself, especially in the long term.


Eligibility criteria:
patients with anorexia nervosa: inclusion criteria: * female sex * age: 18 years or older * diagnosis of anorexia nervosa in the acute phase * hospitalized at the division of eating and nutrition disorders (end), san giuseppe hospital, istituto auxologico italiano, irccs, piancavallo (vb), italy exclusion criteria: * absence of signed informed consent control group: inclusion criteria: * female sex * age: 18 years or older * bmi between 18.5 and 24.9 kg/m2 exclusion criteria: * absence of signed informed consent

Keywords: anorexia nervosa sphingolipids females lipidomic profile
long-term safety study of ta-7284 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of ta-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in japanese patients with type 2 diabetes mellitus on 52 weeks oral administration.

this is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of ta-7284 in japanese patients with type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. the patients will receive either ta-7284-low or ta-7284-high orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Eligibility criteria:
inclusion criteria: * men or women age ≥20 years old * diagnosed with type 2 diabetes mellitus at least 3 months before screening * hba1c of ≥7.0% and ≤10.0% (monotherapy group) * hba1c of ≥7.0% and ≤10.5% (combination therapy group) exclusion criteria: * type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus * past or current history of severe diabetic complications * fasting plasma glucose \> 270 mg/dl before treatment start * history of hereditary glucose-galactose malabsorption or primary renal glucosuria * patients requiring insulin therapy

Keywords: ta-7284 jnj-28431754 canagliflozin sodium glucose co-transporter (sglt2 inhibitor)